Exhibit 99.1 Cadrenal Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Announces strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis Highlights from the Quarter Ended June 30, 2025, and Other Recent Events: Clinical Trial Developments In August 2025, Cadrenal announced plans to initiate a clinical trial for its late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dial ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements for the period ended June 30, 2025, show decreased cash and total assets, an increased net loss of $7.5 million, and higher cash used in operations [Balance Sheets](index=4&type=section&id=Balance%20Sheets) As of June 30, 2025, total assets decreased to **$6.0 million** from **$10.1 million**, driven by reduced cash, with liabilities and equity also falling Balance Sheet Summary (Unaudited) | Account | June 30, 2025 ($M) | December 31, 2024 ($M) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5.57M | $10.02M | | Total current assets | $5.97M | $10.11M | | **Total assets** | **$5.98M** | **$10.12M** | | **Liabilities & Equity** | | | | Total current liabilities | $1.68M | $2.68M | | **Total liabilities** | **$1.68M** | **$2.68M** | | Accumulated deficit | $(33.24M) | $(25.72M) | | **Total stockholders' equity** | **$4.30M** | **$7.44M** | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for the six months ended June 30, 2025, increased to **$7.5 million**, driven by higher operating expenses, particularly General and Administrative costs Operating Results (Unaudited) | Metric | Three Months Ended June 30, 2025 ($M) | Three Months Ended June 30, 2024 ($M) | Six Months Ended June 30, 2025 ($M) | Six Months Ended June 30, 2024 ($M) | | :--- | :--- | :--- | :--- | :--- | | General and administrative expenses | $2.66M | $1.21M | $4.91M | $2.34M | | Research and development expenses | $1.08M | $1.25M | $2.75M | $1.88M | | **Loss from operations** | **$(3.73M)** | **$(2.47M)** | **$(7.66M)** | **$(4.22M)** | | **Net loss** | **$(3.67M)** | **$(2.39M)** | **$(7.51M)** | **$(4.06M)** | | **Net loss per share (basic and diluted)** | **$(1.87)** | **$(2.24)** | **$(3.95)** | **$(3.80)** | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities more than doubled to **$7.7 million** for the six months ended June 30, 2025, resulting in a **$4.4 million** net decrease in cash Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,674,557) | $(3,365,624) | | Net cash used in investing activities | $(3,251) | $0 | | Net cash provided by financing activities | $3,230,596 | $298 | | **Net change in cash and cash equivalents** | **$(4,447,212)** | **$(3,365,326)** | | **Cash and cash equivalents – end of period** | **$5,570,730** | **$5,037,174** | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) Notes highlight tecarfarin development, going concern uncertainty, a **1-for-15 reverse stock split**, and recent ATM equity sales - The company is a biopharmaceutical firm developing **tecarfarin**, a novel oral anticoagulant, for cardiovascular conditions like **end-stage kidney disease with atrial fibrillation (ESKD+AFib)** and for patients with **left ventricular assist devices (LVADs)**[21](index=21&type=chunk)[22](index=22&type=chunk) - The company's cash balance of approximately **$5.0 million** as of August 6, 2025, is expected to fund operations for at least the **next twelve months**[27](index=27&type=chunk) However, **additional funding** is necessary for further late-stage clinical trials, including a **Phase 3 trial** for tecarfarin[28](index=28&type=chunk) - A **1-for-15 reverse stock split** was effected on August 20, 2024[63](index=63&type=chunk) All share and per-share data have been retroactively adjusted to reflect this split[63](index=63&type=chunk) - During the six months ended June 30, 2025, the company sold **186,294 shares** through its **at-the-market (ATM) facility**, generating net proceeds of approximately **$3.2 million**[73](index=73&type=chunk) - Subsequent to the quarter end, from July 1 to July 14, 2025, the company sold an additional **39,741 shares** via its **ATM facility**, raising net proceeds of approximately **$499,000**[90](index=90&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management focuses on tecarfarin for niche cardiovascular conditions; H1 2025 operating expenses increased, requiring additional capital for future clinical trials - The company is pursuing a 'pipeline-in-a-product' approach for **tecarfarin**, targeting niche cardiovascular conditions where DOACs have failed or are unproven, such as in patients with **ESKD and AFib**, or those with **LVADs**[97](index=97&type=chunk)[98](index=98&type=chunk) - On **August 5, 2025**, the company announced plans to initiate a **clinical trial** for tecarfarin in patients with **ESKD transitioning to dialysis**, with enrollment expected to begin later in the year[100](index=100&type=chunk) - As of August 11, 2025, the company had approximately **$5.0 million** in cash and cash equivalents, which is expected to fund operations for at least the **next twelve months**[113](index=113&type=chunk) However, **additional funding** is needed for any further clinical trials, including a **Phase 3 trial** for tecarfarin[113](index=113&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Total operating expenses increased to **$7.7 million** for the six months ended June 30, 2025, driven by significant increases in G&A and R&D Comparison of Operating Expenses (Six Months Ended June 30) | Expense Category | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $4,910,970 | $2,338,430 | $2,572,540 | 110% | | Research and development | $2,745,379 | $1,882,736 | $862,643 | 46% | | **Total operating expenses** | **$7,662,267** | **$4,222,233** | **$3,440,034** | **81.5%** | - The **$2.6 million** increase in G&A expenses for the six-month period was primarily due to a **$1.3 million** rise in public company costs, a **$0.6 million** increase in stock-based compensation, and a **$0.2 million** increase in personnel-related expenses[110](index=110&type=chunk) - The **$0.9 million** increase in R&D expenses for the six-month period was mainly attributed to a **$0.5 million** increase in CMC expenses, a **$0.3 million** increase in personnel costs (severance), and a **$0.1 million** increase in clinical trial preparation costs[111](index=111&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations through equity sales; cash used in operations increased to **$7.7 million** in H1 2025, partially offset by **$3.2 million** from financing Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Cash used in operating activities | $(7,674,557) | $(3,365,624) | | Cash provided by financing activities | $3,230,596 | $298 | | **Net change in cash** | **$(4,447,212)** | **$(3,365,326)** | - Cash used in operating activities for the first six months of 2025 was **$7.7 million**, driven by a net loss of **$7.5 million** (which included **$1.1 million** of non-cash expenses) and a **$1.3 million** use of cash from changes in operating assets and liabilities[113](index=113&type=chunk)[115](index=115&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - The company is a **smaller reporting company** and is not required to provide these disclosures[121](index=121&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** at the **reasonable assurance level**[123](index=123&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have **materially affected**, or are reasonably likely to materially affect, internal controls[124](index=124&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is **not currently a party** to any **material legal proceedings**[126](index=126&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report - There have been **no material changes** from the risk factors disclosed in the company's Annual Report[127](index=127&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On June 29, 2025, the company issued **10,000 shares** of restricted common stock to a consultant, exempt from registration under Section 4(a)(2) - On **June 29, 2025**, the company issued **10,000 shares** of **restricted common stock** to a consultant for services, exempt from registration under **Section 4(a)(2) of the Securities Act**[129](index=129&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20Other%20Information) On May 9, 2025, the CEO and CFO entered into Rule 10b5-1 stock selling plans for up to **50,600** and **33,333 shares**, effective August 2025 - On **May 9, 2025**, the CEO and CFO entered into **Rule 10b5-1 stock selling plans**[135](index=135&type=chunk) - The plans allow for the sale of a maximum of **50,600 shares** by the CEO and **33,333 shares** by the CFO, with the selling period beginning in **August 2025** and ending in **November 2025**[136](index=136&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed or furnished as part of the Quarterly Report on Form 10-Q - The report includes an **Exhibit Index** listing all documents filed or furnished with the **Form 10-Q**[137](index=137&type=chunk)

[Corporate Update and Q1 2025 Highlights](index=1&type=section&id=Corporate%20Update%20and%20Q1%202025%20Highlights) Cadrenal strengthened leadership, advanced tecarfarin's clinical development with FDA guidance and Abbott collaboration, and enhanced supply chain security [Leadership and Regulatory Updates](index=1&type=section&id=Leadership%20and%20Regulatory%20Updates) Cadrenal appointed a Chief Medical Officer and gained FDA guidance for its pivotal tecarfarin Phase 3 trial design - Appointed **James J. Ferguson, M.D., FACC, FAHA**, as Chief Medical Officer to lead business development review and the late-stage clinical development of tecarfarin[4](index=4&type=chunk) - Following a Type D meeting in February 2025, the FDA provided additional guidance on the design for a Phase 3 tecarfarin trial and is open to reviewing a final study design[5](index=5&type=chunk) [Strategic Collaborations and Operational Milestones](index=1&type=section&id=Strategic%20Collaborations%20and%20Operational%20Milestones) Cadrenal collaborated with Abbott for the TECH-LVAD trial, secured U.S. tecarfarin manufacturing, and confirmed market potential - Announced a Collaboration Agreement with Abbott in March 2025 to support the pivotal TECH-LVAD trial, with Abbott providing insights, trial design support, and HeartMate 3™ expertise[6](index=6&type=chunk) - Successfully transferred the manufacturing of tecarfarin drug substance (API) from a CDMO in Asia to one in the United States to improve supply chain security[7](index=7&type=chunk) - Market research indicates the LVAD market is projected to nearly **double by 2032**, positioning tecarfarin for significant clinical value[8](index=8&type=chunk) [Corporate Visibility and Development](index=2&type=section&id=Corporate%20Visibility%20and%20Development) Cadrenal enhanced corporate visibility through conference participation and is exploring new pipeline and collaboration opportunities - Participated in key conferences including the J.P. Morgan Healthcare Conference and the BIO CEO and Investor Conference to build corporate visibility[9](index=9&type=chunk) - The company is actively exploring opportunities to add to its clinical pipeline and collaborate with partners to advance tecarfarin development for LVADs and other indications[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Cadrenal reported an increased net loss in Q1 2025 due to higher R&D and G&A expenses, with reduced cash reserves [Financial Performance (Statement of Operations)](index=2&type=section&id=Financial%20Performance%20%28Statement%20of%20Operations%29) Cadrenal's Q1 2025 net loss increased to $3.8 million, or ($2.09) per share, driven by higher R&D and G&A expenses Financial Performance Summary | Metric | Q1 2025 (USD) | Q1 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Research and Development Expenses | $1.7 million | $0.6 million | +183% | | General and Administrative Expenses | $2.3 million | $1.1 million | +109% | | **Net Loss** | **$3.8 million** | **$1.7 million** | **+123.5%** | | Net Loss Per Share | ($2.09) | ($1.56) | Increased Loss | [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20%28Balance%20Sheet%29) As of March 31, 2025, Cadrenal's cash decreased to $7.3 million, with total assets at $8.0 million and equity at $6.1 million Financial Position Summary | Metric | March 31, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $7.3 million | $10.0 million | | Total Assets | $8.0 million | $10.1 million | | Total Liabilities | $1.8 million | $2.7 million | | Total Stockholders' Equity | $6.1 million | $7.4 million | [About Cadrenal Therapeutics, Inc.](index=2&type=section&id=About%20Cadrenal%20Therapeutics%2C%20Inc.) Cadrenal Therapeutics develops cardiovascular treatments, with tecarfarin as its lead product, holding Orphan Drug and Fast Track designations for multiple indications - Cadrenal's lead product is **tecarfarin**, a novel oral vitamin K antagonist anticoagulant designed to address unmet needs in chronic anticoagulation therapy[13](index=13&type=chunk) - The company is pursuing a **'pipeline-in-a-product' approach** with tecarfarin[14](index=14&type=chunk) - Tecarfarin has received **Orphan Drug Designation (ODD)** for patients with LVADs and both **ODD and Fast Track status** for end-stage kidney disease with atrial fibrillation (ESKD+AFib)[14](index=14&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For Q1 2025, Cadrenal Therapeutics reported a net loss of $3.8 million, with total assets decreasing to $7.95 million and cash used in operations of $4.6 million [Balance Sheets](index=4&type=section&id=Balance%20Sheets) Total assets decreased from $10.1 million at year-end 2024 to $7.95 million by March 31, 2025, primarily due to reduced cash and equivalents Balance Sheet Summary (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,336,072 | $10,017,942 | | Total current assets | $7,944,792 | $10,112,797 | | **Total assets** | **$7,953,262** | **$10,123,533** | | **Liabilities & Equity** | | | | Total current liabilities | $1,840,166 | $2,683,958 | | **Total liabilities** | **$1,840,166** | **$2,683,958** | | **Total stockholders' equity** | **$6,113,096** | **$7,439,575** | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss for Q1 2025 more than doubled to $3.85 million, driven by significant increases in both G&A and R&D expenses Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | General and administrative expenses | $2,254,577 | $1,125,993 | | Research and development expenses | $1,667,882 | $629,025 | | Total operating expenses | $3,927,976 | $1,755,615 | | Loss from operations | $(3,927,976) | $(1,755,615) | | **Net loss and comprehensive loss** | **$(3,845,380)** | **$(1,663,288)** | | **Net loss per common share, basic and diluted** | **$(2.09)** | **$(1.56)** | [Statements of Changes in Stockholders' Equity](index=6&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased to $6.11 million by March 31, 2025, primarily due to the quarterly net loss, partially offset by stock sales and equity compensation - Key changes in stockholders' equity for the three months ended March 31, 2025 include a **net loss of $3,845,380**, proceeds from the sale of common stock of **$1,970,136** (net of costs), and equity-based compensation of **$518,890**[16](index=16&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $4.6 million for the quarter, partially offset by $2.0 million from financing activities Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,648,755) | $(1,836,380) | | Net cash used in investing activities | $(3,251) | $0 | | Net cash provided by financing activities | $1,970,136 | $298 | | **Net change in cash** | **$(2,681,870)** | **$(1,836,082)** | | **Cash and cash equivalents – end of the period** | **$7,336,072** | **$6,566,418** | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) The notes detail the company's focus on tecarfarin, its liquidity position, and significant financial events including a reverse stock split and ATM sales - The company is a biopharmaceutical firm developing tecarfarin, a novel oral anticoagulant, for cardiovascular conditions with unmet needs, such as patients with LVADs and ESKD+AFib[22](index=22&type=chunk)[23](index=23&type=chunk) - The company has incurred operating losses since inception, with a **net loss of $3.8 million** and an **accumulated deficit of $29.6 million** as of March 31, 2025[26](index=26&type=chunk)[28](index=28&type=chunk) - Cash and cash equivalents of **$7.3 million** are expected to fund operations for at least the next twelve months, but additional funding is required for late-stage clinical trials[29](index=29&type=chunk) - On August 20, 2024, the company effected a **1-for-15 reverse stock split**, with all share and per-share amounts retroactively adjusted[62](index=62&type=chunk) - During Q1 2025, the company sold **102,246 shares** through its ATM facility, raising approximately **$2.0 million** in net proceeds[72](index=72&type=chunk) - From April 1, 2025, through May 7, 2025, the company sold an additional **56,943 shares** via its ATM facility, raising net proceeds of approximately **$876,000**[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased operating expenses due to public company costs and R&D, confirming sufficient liquidity for 12 months but noting the need for future trial funding [Company Overview](index=21&type=section&id=Company%20Overview) Cadrenal is developing tecarfarin as a novel oral anticoagulant for specific cardiovascular conditions, leveraging orphan drug and fast-track designations - The company is focused on developing tecarfarin for rare cardiovascular conditions where patients cannot achieve reliable anticoagulation with warfarin and where DOACs have failed or are unproven[95](index=95&type=chunk) - Tecarfarin has received FDA orphan drug designation for patients with implanted mechanical circulatory support devices and both orphan drug and fast-track designations for patients with end-stage kidney disease and atrial fibrillation[96](index=96&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating expenses for Q1 2025 increased by $2.2 million (124%) year-over-year, driven by higher G&A and R&D costs Results of Operations Comparison | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | General and administrative expenses | $2,254,577 | $1,128,584 | +$1,125,993 | | Research and development expenses | $1,667,882 | $629,025 | +$1,038,857 | | **Total operating expenses** | **$3,927,976** | **$1,755,615** | **+$2,172,361** | | **Net loss** | **$(3,845,380)** | **$(1,663,288)** | **+$(2,182,092)** | - The **$1.1 million increase in G&A expenses** was primarily due to a **$0.7 million increase** in public company-related expenses, a **$0.2 million increase** in stock-based compensation, and a **$0.2 million increase** in personnel costs[102](index=102&type=chunk) - The **$1.0 million increase in R&D expenses** was mainly attributed to a **$0.5 million increase** in CMC expenses, **$0.1 million** in clinical trial preparation, **$0.2 million** in stock-based compensation, and **$0.3 million** in personnel-related expenses, including severance[103](index=103&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company has funded operations through equity sales and expects current cash to last 12 months, but substantial additional capital is needed for late-stage clinical trials - As of May 8, 2025, the company had approximately **$6.9 million** in cash and cash equivalents[105](index=105&type=chunk) - Management believes current cash is sufficient to fund operations for at least the next twelve months, but additional funding is necessary to conduct further late-stage clinical trials, including a Phase 3 trial for tecarfarin[105](index=105&type=chunk) [Cash Flows](index=24&type=section&id=Cash%20Flows) Cash used in operating activities significantly increased to $4.6 million in Q1 2025, partially offset by $2.0 million from financing activities via the ATM facility - Cash used in operating activities in Q1 2025 was **$4.6 million**, driven by a **$3.3 million** cash-adjusted net loss and a **$1.3 million** use of cash from changes in operating assets and liabilities[107](index=107&type=chunk) - Cash provided by financing activities in Q1 2025 totaled **$2.0 million** from the use of the company's ATM facility[109](index=109&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company is a smaller reporting company - The company is a smaller reporting company and is not required to provide these disclosures[113](index=113&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[114](index=114&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[115](index=115&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company reports no current material legal proceedings[117](index=117&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K - The company states there have been no material changes from the risk factors described in its Annual Report[118](index=118&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued restricted common stock to a consultant and granted stock options to officers and directors, exempt from registration - On January 8, 2025, the company issued **25,000 shares** of restricted common stock to a consultant for services, exempt from registration under Section 4(a)(2) of the Securities Act[120](index=120&type=chunk) - On January 23, 2025, the company issued stock options to purchase **220,000 shares** to officers and directors under its 2022 Successor Equity Incentive Plan, with an exercise price of **$19.79 per share**[121](index=121&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during Q1 2025 - During Q1 2025, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement[126](index=126&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed or furnished as part of the Quarterly Report on Form 10-Q

Financial Performance - Cadrenal raised approximately $9.8 million in financing transactions during the year ended December 31, 2024, including $5.1 million through an at-the-market facility and $4.7 million from warrant exercises[9]. - Research and development expenses for the year ended December 31, 2024, were $4.2 million, compared to $4.1 million for the year ended December 31, 2023[14]. - General and administrative expenses for the year ended December 31, 2024, were $6.8 million, compared to $3.5 million for the year ended December 31, 2023[14]. - Cadrenal reported a net loss of $10.7 million for the year ended December 31, 2024, compared to a net loss of $8.4 million for the year ended December 31, 2023[14]. - As of December 31, 2024, Cadrenal's cash and cash equivalents totaled $10.0 million, an increase from $8.4 million as of December 31, 2023[15]. Leadership Changes - The company appointed James J. Ferguson, MD, as Chief Medical Officer and Jeff Cole as Chief Operating Officer to strengthen its leadership team[6]. Clinical Development - A collaboration agreement with Abbott was announced to support the pivotal TECH-LVAD trial for tecarfarin, leveraging insights from recent HeartMate 3 clinical trials[4]. - The FDA provided additional guidance for the design of a future Phase 3 trial of tecarfarin during a Type D meeting held on February 3, 2025[5]. - Cadrenal received FDA Orphan Drug Designation for tecarfarin in April 2024, highlighting its potential impact on rare cardiovascular conditions[11]. - The company is exploring collaborations with potential development partners to advance tecarfarin's pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions[8].

Drug Development and Clinical Trials - Tecarfarin is being developed as a novel oral anticoagulant for patients with rare cardiovascular conditions, addressing unmet needs in anticoagulation therapy[29]. - Tecarfarin has been evaluated in 11 clinical trials involving over 1,000 individuals, with only 1.6% of patients experiencing major bleeding in the Phase 2/3 EMBRACE-AC trial[44]. - The company entered a collaboration agreement with Abbott to support the Phase 3 TECH-LVAD study, which will evaluate tecarfarin's efficacy and safety in LVAD patients[34][36]. - Tecarfarin has been evaluated in 11 human clinical trials involving over 1,000 individuals, including eight Phase 1 trials, two Phase 2 trials, and one Phase 2/3 trial[50]. - In the EMBRACE-AC study, the Time in Therapeutic Range (TTR) for tecarfarin was significantly higher than the TTR in a subset of warfarin-treated patients, with major bleeding events occurring in only 1.6% of tecarfarin subjects compared to 3.6% for warfarin[53]. - The company plans to initiate a pivotal Phase 3 clinical trial for tecarfarin in late 2025 or early 2026, subject to funding, with the potential for a single pivotal trial to be sufficient for NDA filing[55]. - Tecarfarin is proposed as a solution for patients with LVADs, end-stage kidney disease, and other conditions where current anticoagulants are contraindicated[77]. - The clinical program for tecarfarin aims to address the significant thrombosis patient population in need of alternative anticoagulation treatments[78]. - The planned Phase 3 trial will involve approximately 450 HeartMate 3 LVAD patients, with a non-inferiority margin of about 10%[105]. - Tecarfarin has been tested in eleven clinical trials, but there is no guarantee that results from earlier phases will be replicated in the pivotal Phase 3 study[191]. Regulatory and Approval Process - The FDA granted tecarfarin orphan drug designation in 2019 for preventing systemic thromboembolism in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), with approximately 100,000 to 150,000 ESKD patients also having AFib[39][48]. - The FDA acknowledged that a non-inferiority trial with a primary composite clinical endpoint could be a feasible path forward for tecarfarin's development[37]. - The FDA requires substantial data demonstrating the quality, safety, and efficacy of a new drug before it can be marketed, which typically takes many years[125]. - The FDA may grant orphan drug designation for drugs intended to treat rare diseases, which can provide a seven-year exclusive marketing period and grant funding of up to $500,000 per year for four years[141]. - Accelerated approval pathways exist for drugs that meet serious conditions and fill unmet medical needs, allowing for early approval based on surrogate endpoints[144]. - The FDA's Fast Track designation for tecarfarin does not ensure a faster development or approval process[199]. - Orphan Drug Designation does not guarantee FDA approval or marketing exclusivity, and the company may face competition even with such designation[214]. - Post-approval, tecarfarin will be subject to ongoing regulatory obligations, which may include costly post-marketing trials and compliance requirements[215]. Financial and Business Development - The company is pursuing business development strategies, including licenses and funding partnerships, to support the Phase 3 study of tecarfarin[35]. - The company requires additional capital to fund the Phase 3 clinical trial, as current cash reserves are insufficient[108]. - The company has not generated any revenue from operations to date and expects to continue incurring significant operating losses in connection with the development and sale of its product candidate, tecarfarin[181]. - The company anticipates that its existing cash and cash equivalents will be sufficient to meet its anticipated cash requirements for at least the next twelve months, but will require additional financing for its planned pivotal Phase 3 clinical trial[185]. - The company will need to raise additional capital to fund its development and commercialization efforts for tecarfarin, and failure to do so could delay or curtail product development[184]. - The company faces significant competition from established pharmaceutical companies and generic products, particularly warfarin and DOACs[112]. - Significant investment will be required for the development and commercialization of tecarfarin, with revenues dependent on successful regulatory approval[207]. Market Opportunity and Competition - There are approximately 15,000 patients in the U.S. with LVADs, indicating a significant market opportunity for tecarfarin in this patient group[57]. - Current standard of care with warfarin yields suboptimal anticoagulation levels, leading to excess bleeding complications in LVAD patients[58]. - The company faces substantial competition in the development and commercialization of new drugs, particularly with its product candidate tecarfarin, which aims to prevent heart attacks and strokes[228]. Manufacturing and Supply Chain - Manufacturing will be outsourced to third-party contract pharmaceutical manufacturers, with no long-term supply agreements in place yet[109]. - The company currently lacks long-term supply agreements for tecarfarin, relying on third-party manufacturers for production and distribution[219]. - Any disruption in third-party manufacturing could increase development costs and impact timelines for commercialization[221]. - The company faces uncertainties related to the costs of manufacturing its clinical product and establishing a commercial drug supply[187]. - Contract manufacturers must comply with stringent FDA regulations, and any failure could result in significant delays or sanctions, adversely affecting the company's operations and financial condition[223]. Risks and Challenges - The company has a limited operating history and has not yet demonstrated the ability to successfully run a clinical trial, which poses significant risks to its business model[179]. - The company is subject to risks related to its financial position and need for capital, including the potential inability to secure sufficient funding on acceptable terms[186]. - The company may face delays in clinical trials due to unforeseen safety issues, recruitment challenges, and regulatory compliance, which could increase development costs and delay completion[204]. - Even with successful clinical trials, regulatory approval is not guaranteed, and the company may face ongoing regulatory obligations post-approval[196][200]. - The company may experience supply shortages if contract manufacturers cannot scale production to meet future clinical or commercial demands[226].

Core Insights - Cadrenal Therapeutics, Inc. has been awarded the 2024 "Anticoagulation Therapy Company of the Year" by Pharma Tech Outlook for its innovative development of tecarfarin, a new vitamin K antagonist anticoagulant aimed at patients with implanted cardiac devices and rare cardiovascular conditions [1][3] Company Overview - Cadrenal Therapeutics is a late-stage biopharmaceutical company focused on developing tecarfarin to provide safer and superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions [4] - The company aims to address significant unmet needs in anticoagulation therapy, particularly for patients with left ventricular assist devices (LVADs) and those with end-stage kidney disease (ESKD) [4] Product Development - Tecarfarin is designed to overcome challenges associated with warfarin therapy, including drug-drug interactions and the need for frequent dosing adjustments [2][4] - The unique metabolic pathway of tecarfarin is less affected by drug interactions and kidney impairment, allowing for a stable, once-daily dosing regimen [2][4] - The product has received orphan drug and fast-track designations, positioning it to fill gaps in chronic anticoagulation treatment options for specific patient populations [3][4] Market Positioning - The company is advancing a pivotal trial for tecarfarin and is pursuing clinical and commercial partnerships, with plans to study its application in mechanical heart valve patients facing anticoagulation difficulties [4]

Core Insights - Cadrenal Therapeutics is developing tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, aimed at providing safer chronic anticoagulation for patients with implanted cardiac devices, particularly those with left ventricular assist devices (LVADs) [1][4] - A presentation at the EACTS Mechanical Circulatory Support Summit highlighted tecarfarin's historical data and a proposed clinical trial protocol to evaluate its effectiveness compared to warfarin in patients using the Abbott HeartMate3 LVAD [1][2] Company Overview - Cadrenal Therapeutics is a late-stage biopharmaceutical company focused on tecarfarin, which is expected to result in fewer adverse events compared to warfarin, including strokes, heart attacks, and bleeding [4] - The company has received orphan drug designation for advanced heart failure patients with LVADs and fast-track status for end-stage kidney disease patients with atrial fibrillation [4] Clinical Trial Insights - The proposed TECH-LVAD trial aims to study tecarfarin's potential to reduce bleeding events associated with the use of the HM3 LVAD in advanced heart failure patients [3] - Historical data presented indicated an inverse relationship between bleeding rates and time in therapeutic range (TTR) for HM3 patients, suggesting tecarfarin may improve TTR [2][3] Future Plans - Cadrenal is actively engaging with the FDA and Abbott to advance the tecarfarin study in LVAD patients, with plans for investigator outreach and patient recruitment [3] - The company is also exploring pivotal clinical trials and potential partnerships to further develop tecarfarin for patients with mechanical heart valves facing anticoagulation challenges [4]

Financial Performance - The net loss for the three months ended September 30, 2024, was $2,407,829, compared to a net loss of $1,036,451 for the same period in 2023[109]. - The net loss for the nine months ended September 30, 2024, was $6,464,099, which included $656,987 of non-cash expenses[117]. - Cash used in operating activities totaled $5,566,844 for the nine months ended September 30, 2024, compared to $2,835,878 in the same period of 2023[118]. - Cash flows from operating activities showed a net loss adjusted for non-cash items using $5,807,112 in cash for the nine months ended September 30, 2024[119]. Research and Development - Tecarfarin is being developed as a new Vitamin K Antagonist (VKA) chronic anticoagulant to prevent heart attacks, strokes, and deaths due to thrombosis in patients with implanted cardiac devices or rare cardiovascular conditions[90]. - Tecarfarin has been evaluated in eleven clinical trials involving over 1,000 individuals, with only 1.6% of patients experiencing major bleeding in the largest trial[95]. - The average time in the therapeutic range for patients using warfarin was only 56%, significantly below the target of 70%, indicating a need for improved anticoagulation options[99]. - The company expects to require additional funding to complete its planned Phase 3 clinical trial and submit its New Drug Application[117]. Expenses - The company reported a 222% increase in research and development expenses, totaling $784,646 for the three months ended September 30, 2024, compared to $243,948 for the same period in 2023[107]. - General and administrative expenses rose by 87% to $1,674,905 for the three months ended September 30, 2024, up from $898,051 in the prior year[106]. - General and administrative expenses increased by $1,365,929, or 52%, to $4,013,336 for the nine months ended September 30, 2024, compared to $2,647,407 for the same period in 2023[112]. - Research and development expenses decreased to $2,667,382 for the nine months ended September 30, 2024, down from $3,720,222 in the prior year, primarily due to a $3.0 million expense in 2023 related to stock issuance[113]. Financing Activities - The company generated gross proceeds of $7,000,000 from its initial public offering (IPO) on January 24, 2023, selling 93,333 shares at $75.00 per share[100]. - In a private placement on July 12, 2023, the company raised approximately $7.5 million by selling 86,667 shares and warrants[101]. - The company sold 154,144 shares through its at-the-market (ATM) facility, generating gross proceeds of $1,635,777 during the quarter ended September 30, 2024[103]. - Net cash provided by financing activities was $1,528,244 for the nine months ended September 30, 2024, significantly lower than $11,915,991 in the prior year due to the completion of the IPO[122]. - The company utilized its ATM facility, generating proceeds of $1,527,946 during the nine months ended September 30, 2024[121]. Cash Position - As of November 7, 2024, the company had cash and cash equivalents of approximately $11.3 million, expected to fund operations for at least the next twelve months[117]. - The company recorded a $740,139 loss on extinguishment of debt during the nine months ended September 30, 2023, with no such activity in 2024[116].

Financial Results - Cadrenal Therapeutics, Inc. reported financial results for the fiscal quarter ended September 30, 2024[4]. - The company issued a press release on November 7, 2024, detailing its financial performance[4]. Regulatory Information - The report is not deemed "filed" under the Securities Exchange Act of 1934, ensuring it is not subject to certain liabilities[5]. - The company is classified as an emerging growth company under the Securities Act of 1933[4]. - The press release is attached as Exhibit 99.1 to the Current Report on Form 8-K[6]. - The financial statements and exhibits are furnished with the Current Report on Form 8-K[6]. - The report was signed by Quang Pham, Chairman and CEO of Cadrenal Therapeutics, Inc.[7]. Company Information - The company is headquartered in Ponte Vedra, Florida[2]. - The trading symbol for the company's common stock is CVKD on the Nasdaq Capital Market[3]. - The company has not elected to use the extended transition period for new financial accounting standards[4].